Senior Manufacturing Cell Processing Supervisor

Responsibilities:

Supervision:

• Provides direct guidance, supervision, and task assignments to manufacturing personnel, maintaining a physical presence on the floor during all critical process steps.
• Coach, develop, and train direct reports to enhance their abilities and expertise.
• Responsible for conducting one on one meetings, performance reviews and assisting with career development.
• Support recruiting, staffing, hiring, onboarding, and performance management of team.
• Maintain individual training plans and ensure team remains up to date with training readiness.

Production Management:

• Ensure completeness and accuracy of all documentation at the end of every shift.
• Assist with the managing of the day-to-day operations and scheduling of Manufacturing Personnel.
• Facilitate the transition of new processes from Product Development to manufacturing.
• Monitor production processes and adjust schedules as needed.
• Coordinates the production schedule and coordinates raw material inventory with support of Supply Chain personnel.
• Performs cGMP manufacturing tasks in an aseptic manner in an aseptic environment.
• Executes routine transactions with the ERP system, including material requisitions, production tracking, updating work orders and production BOMs, etc.
• Clearly communicates problems and observations with management from other departments.

Quality Assurance, Safety, and Compliance:

• Reviews and approves Batch Records, Change Controls, Deviations and other manufacturing documentation required for cGMP production operations.
• Ensures overall cGMP compliance with the department and represents manufacturing during project team meetings or during external audits.
• Enforce safety protocols and procedures to ensure a safe working environment.
• Ensure compliance with all relevant regulations and standards.
• Deliver to Plan: Lead and direct the safety, quality, and daily production operations for suite. Oversee all tasks on the floor as they are carried out and aid with troubleshooting where required. Coordinate with other departments to ensure on time delivery of the production schedule.
• Monitor and coach staff to ensure full compliance with GMP and Quality system requirements, maintaining inspection readiness and minimal errors. Lead and oversee the on-time completion of document review (batch record, logbook, SOPs) for completeness, clarity, accuracy to support on-time release of batches with minimal errors.
• Adapts departmental plans and priorities to address resource and operational challenges.
• Collaborate effectively with Senior Management in a dynamic environment, demonstrating outstanding communication skills.
• Maintain continuous readiness of the manufacturing facility for production and GMP audits.
• Administrative tasks - leading shift exchange, assigning duties, attending meetings, sending/receiving emails, and participating in continuous improvement projects. Demonstrate strong technical writing abilities (deviation initiations, SOP creation, etc.).
• Perform other duties as assigned

Qualifications:

• 4+ years' experience in manufacturing (7+ years' experience without AS/BS); GMP setting preferred, previous supervisory experience required.
• Computer software skills, organization, record keeping and planning skills, budget preparation, training skills, multiple projects, time management, facilitation skills
• Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues. Must have experience in writing technical documents and protocols.
• Proven logic and decision-making abilities, critical thinking skills. Aseptic practices and clean room operations
• Statistical and auditing techniques
• Environmental control procedures/equipment
• Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Downstream Operations
• Strong knowledge of current industry trends and can use the latest technologies.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

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